GORE VIABAHN Endoprosthesis with Heparin VBH091002ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 35 9mmX10cm 9Fr 120cmCath · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis with Heparin (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623181), received between Aug 27, 2019 and Aug 27, 2019 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING AN ENDOVASCULAR PROCEDURE. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS UTILIZED. TWO GORE® VIABAHN® ENDOPROSTHESES WERE IMPLANTED AND THEN EXPLANTED DURING THE PROCEDURE. ON (B)(6) 2019 IT WAS LEARNED THAT THE DEVICES WERE EXPLANTED IN A CONVERSION TO OPEN REPAIR BECAUSE THERE WAS BLEEDING THAT COULD NOT BE CONTROLLED ENDOVASCULARLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blood Loss
MAUDE report 8937903 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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